Regulatory Affairs Syndicator

Pfizer Inc. should get U.S. approval to market its Celebrex arthritis-pain pill for use in children because the benefits outweigh the risks, a Food and Drug Administration advisory panel said Wednesday.

Drug Importation – Issue Brief – July 2005Manufacturers’ Blog, DC - 2 hours ago… The key regulatory agencies – the Food and Drug Administration, the US Customs Service and the Drug Enforcement Administration – all oppose drug …

Akorn Gets Tentative FDA Nod on DrugForbes, NY - 46 minutes ago… said Thursday the Food and Drug Administration granted its generic version of Novartis' Voltaren ophthalmic solution tentative approval. … Akorn's generic equal of …

NIH Office of the Director (OD), “NIH Announces More Than 50 Awards in the Pathway to Independence Program”, November 30, 2006

Diagnostics and drug developer Akorn Inc. said Thursday the Food and Drug Administration granted its generic version of Novartis’ Voltaren ophthalmic solution tentative approval.

Study: Drug-coating increases risk fivefold With a new report blaming drug-coated heart stents for a fivefold increase in the risk of clotting problems and a Food and Drug Administration panel poised to investigate the devices next week, hospitals that once embraced the new stents are starting to retreat to an older, cheaper version.

With a new report blaming drug-coated heart stents for a fivefold increase in the risk of clotting problems and a Food and Drug Administration panel poised to investigate the devices next week, hospitals that …
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BUFFALO GROVE, Ill.—-Akorn, Inc. today announced that the U.S. Food and Drug Administration has granted tentative approval for Akorn’s Abbreviated New Drug Application for Diclofenac Sodium Ophthalmic Solution 0.1% in 2.5 ml and 5 ml dropper bottles.

National Institute of Allergy and Infectious Diseases (NIAID), International HIV/AIDS Trial Finds that Risks of Death, AIDS and Other Major Diseases Increase on Episodic Antiretroviral Therapy;
November 29, 2006

Tokyo, Nov 30, 2006 (JCN) - Daiichi Sankyo announced November 29 that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for a fixed dose combination of two antihypertensives, the calcium channel blocker (CCB) amlodipine besylate (currently marketed by Pfizer as Norvasc) and the angiotensin receptor blocker (ARB) olmesartan medoxomil, or Benicar.

They want Pentagon to determine if Factor VII’s risks outweigh benefits Two U.S. senators called on the Pentagon yesterday to investigate the military’s use of a largely experimental blood-coagulating drug that doctors inject into wounded troops to control bleeding but that has been linked to unexpected and potentially deadly blood clots.

Study: Drug-coating increases risk fivefold With a new report blaming drug-coated heart stents for a fivefold increase in the risk of clotting problems and a Food and Drug Administration panel poised to investigate the devices next week, hospitals that once embraced the new stents are starting to retreat to an older, cheaper version.

The Croatia-based Pliva, the subsidiary of the New Jersey-based Barr Pharmaceuticals Inc, has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market pravastatin tablets 10 mg, 20 mg, and 40 mg, the generic version of Bristol-Myers Squibb’s Pravachol (pravastatin sodium) tablets.

Children as young as 2 who suffer from arthritis can be treated with Celebrex, but to ensure the painkiller doesn’t put them at later risk for heart attacks, their health should be tracked for decades, a Food and Drug Administration advisory panel said Wednesday.

NEW YORK, November 30 (newratings.com) – A US FDA (Food and Drug Administration) advisory panel Wednesday recommended that the use of Pfizer Inc’s ( PFE.NYS ) pain reliever Celebrex should be broadened to treat children with juvenile rheumatoid arthritis.